Pearl IRB becomes just the second AAHRPP accredited organization in the state of Indiana by demonstrating high standards of excellence for quality, ethics, and protection in all levels of research.

“We are extremely proud to have earned AAHRPP accreditation. Our clients want to work first and foremost with an IRB that demonstrates excellence, but many also have the business objective of engaging with diverse suppliers in the clinical research space. With Pearl IRB, they get both,” shares Pearl IRB’s President and CEO, Diana Caldwell.

Pearl Pathways’ own COO and Co-Founder, Gretchen Bowker will be holding a webinar on FDA regulatory requirements for the manufacturing and commercialization of dietary supplements via ComplianceOnline. A few of the topics include a review of FDA regulations in the area, history of Dietary Supplement Health and Education Act, and a review of applicable FDA guidance documents. For more information about the webinar, click here.

Do you plan to launch a product into this rapidly growing market? Are you responsible for the manufacturing or distribution of a dietary supplement, food drug, or nutraceutical? If yes, this is the webinar will be informative and valuable for you!

Pearl IRB is one of the four newly accredited organizations in the United States and one of only two AAHRPP accredited organizations in state of Indiana. Additionally, among the list of accredited organizations by AAHRPP include, The National Institutes of Health and Pfizer, Inc., the largest industry sponsor of clinical research.

Pearl IRB’s accreditation demonstrates its value in setting and following high standards for quality, ethics, and protection in all of its research.

Pearl IRB has Full Board meetings scheduled for December 3, 10, and 17. There will be no meetings on December 24 or 31. The regularly scheduled Full Board meetings will resume on January 7, 2015. If you have an urgent IRB concern, please contact us at least two weeks in advance. Happy holidays to all!

We are pleased to announce our recent updates to the Resources section of the Pearl IRB website, where you will find new and revised forms to serve you in the IRB submission process. Some of these changes include:

On January 4th, 1983 President Ronald Reagan signed into effect the Orphan Drug Act. For over 30 years, orphan drug development has grown in volume, and has had a major impact on the biopharma and diagnostics industries. With advancement in technology including increased development of novel companion diagnostics as well as the mapping of the human genome, orphan drug approvals by FDA have continued to rise. New data has been released showing that 2013 was a big year for orphan drug approvals. In 2011, FDA approved 26 orphan drugs. The number dropped slightly in 2012 g to 25, but rebounded in 2013 to a record 31. Orphan drug designations were also high in 2013 reaching a record breaking 260.

It is estimated by PHRMA in a 2013 Medicines in Development report entitled “Rare Diseases: A Report on Orphan Drugs in the Pipeline,” that 30 million Americans have one of the 7000 diseases deemed rare. Rare disease is defined as one affecting under 200,000 people in the United States. Further, this report estimated that there were 452 medicines and vaccines in development for rare disease in 2013. To review this report, click here. To review a recent article in medcitynews.com covering the surge in orphan drug development and approvals, click here.

Pearl Pathways has the pleasure of working with several of our clients on developing the appropriate regulatory strategy, executing global regulatory filings, and assisting with clinical trials for orphan drugs. Contact us if you need assistance with your orphan drug or device.

We anticipate that this focus on orphan drug development will continue among both large pharm and small biotechs. Navigating these diseases in small patient populations is complex and can be daunting, but new technologies and the regulatory landscape have made it a bit easier to impact rare and debilitating diseases.

The 2013 Site Solutions Summit features Pearl Pathways’ own Diana Caldwell. She will be involved in the roundtable discussions as a panelist and moderator for topics such as: Investigator Insider: What your site needs to know about your next potential investigator; and Your Circle of Friends: Why social media matters. The Summit focuses on encouraging dialogue and sharing of information to arrive at best site practices. Diana adds to a group of panelists with years of experience and wisdom to share. Below are the two discussions Diana will partake in:

Roundtable Title: Investigator Insider: What your site needs to know about your next potential investigator.Roundtable Date: Saturday, October 12, 2013

Pearl Pathways’ open house last Thursday the 20th welcomed in the new office with a bang. The afternoon get together was a fun way for visitors to stop by and see the new place. A refurnished interior to an old Indianapolis building on the south side of the city filled with friends, family, clients, and colleagues created a great atmosphere for all. Thank you to everyone that came out for the open house! If you would still like to stop by and see the new office call (317) 899-9341 or email openhouse@pearlpathways.com

Pearl Pathways has moved to our new office! We are excited to share our new home with clients and colleagues. Please join us if you can. Appetizers and refreshments will be served throughout the evening.

Guest commentator and president of the Greater Indianapolis Chamber of Commerce, Scott Miller cited the news of Pearl’s expansion as a sign of the growing life science industry in Indiana in a recent article on nwi.com. Miller’s article describes the current state of the life science industry, as well as speculates the outcomes of future legislation impacting the industry. To read the article on NWI.com, click here.